Serpentine Wire Seal for Paravalvular Heart Implant Gaps
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Solution Overview
Problem
Therapeutic implants in the heart, such as replacement valves and occlusion devices, often experience leakage due to gaps between their circumference and the heart anatomy, which are non-circular and non-rectangular, leading to inefficient blood flow and device performance.
Innovation Solution
A catheter-based deployment system using an elongate wire pre-loaded into a serpentine shape is deployed to fill these gaps, allowing it to conform to any shape and size, reducing the need for threaded actuators and enabling multiple wires to be inserted simultaneously.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If circular or rectangular plugs are used to fill gaps, then the device structure is simple, but the plugs cannot sufficiently plug non-circular gaps to prevent blood flow
Solution Approach 1:
The patent applies asymmetry by using a non-circular, non-rectangular plug shape that specifically matches the crescent-shaped gap geometry. The plug has a curved outer perimeter with a concave section that conforms to the convex surface of the therapeutic implant, creating an asymmetric shape that perfectly fills the asymmetric gap between the implant and heart wall, thereby preventing blood leakage effectively.
2Productivity
If threaded actuators are used to deploy plugs, then the device can be precisely positioned, but only one device can be delivered at a time, increasing cost and implantation time
Solution Approach 1:
The patent merges multiple plug delivery capabilities into a single catheter-based delivery system. The catheter is configured to receive and deliver multiple elongate wires or lengths of wire simultaneously, eliminating the need for separate threaded actuators for each plug. This combining of functions allows multiple plugs to be deployed at once, significantly improving implantation productivity while reducing overall system complexity.
Solution Approach 2:
The patent extracts the threaded actuator mechanism from the plug design, simplifying the plug structure to just the elongate wire or braid without complex actuation components. The delivery function is separated into the catheter system, which uses a push rod to deploy the simplified plug structures, allowing for faster and more efficient implantation.
3Reliability
If discrete sized implants are used, then manufacturing is simplified, but gaps form when implant size does not match anatomy, causing leakage
Solution Approach 1:
The patent applies local quality by using a compliant material for the plug that can locally adapt to the specific geometry of the gap. The plug material deforms to match the local anatomical features and implant surface contours, providing effective sealing at the specific location without requiring custom-manufactured implants for each patient's unique anatomy.
Solution Approach 2:
The patent uses parameter changes by selecting a material with specific mechanical properties (compliance, elasticity) that allow the plug to change its shape and size parameters in response to the gap geometry. This enables the same standardized plug design to effectively seal gaps of varying sizes and shapes by changing its physical parameters rather than requiring different implant sizes.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The solution effectively seals gaps of various shapes and sizes, enhancing the performance of therapeutic implants by preventing blood leakage and reducing implantation costs and time.
Implementation Method 1
The elongate wire may be set (e.g. heat-set) into a serpentine shape that curves between a plurality of peaks and a plurality of troughs. The serpentine shape may make the elongate wire flexible or resilient so that it is biased to return to its heat-set serpentine shape when deformed or constrained.
Implementation Method 2
The push rod can then be moved distally to push the elongate wire out of the notch on the distal end of the catheter.
Implementation Method 3
Moreover, because the elongate wire may be inserted into the gap under tension, the tension may hold the elongate wire within the gap and press against the ends of the gap (e.g. like a compression spring) to narrow or close the gap.
Data Source
Figure 1A~1B
Figure 2
Figure 3
AI summary
Devices, systems, and methods for preventing leakage through a therapeutic implant are provided. An exemplary apparatus includes an elongate wire configured to be implanted within a heart of a patient such that the elongate wire is positioned within a non-circular gap between a therapeutic implant positioned within the heart and a native heart tissue of the patient to stop a leakage of blood through the non-circular gap. The elongate wire comprises a single length of material set in a serpentine shape. Moreover, the elongate wire is configured to retain the serpentine shape when the elongate wire is positioned within the non-circular gap.